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Immutep(IMMP) - 2025 FY - Earnings Call Presentation
2025-11-27 00:30
Annual General Meeting 2025 (ASX:IMM, NASDAQ:IMMP) 1 Empowering the immune system to fight cancer and autoimmune disease For personal use only Forward Looking Statements The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should ...
Translational Data and Significant Pathologic Response Rates from EFTISARC-NEO Phase II Highlighted in Oral Presentation at CTOS 2025
Globenewswire· 2025-11-13 13:00
Novel combination with neoadjuvant eftilagimod alfa (efti) achieves significant 51.5% tumour hyalinization/fibrosis across multiple soft tissue sarcoma subtypes including rare and highly aggressive tumours with poor prognosisEarly translational data show a strong immune system activation inline with efti’s mode of action with statistically-significant increases in multiple cytokines and chemokines High levels of key immune proteins in EFTISARC-NEO including interferon-gamma (IFN-γ) correlate with pathologic ...
Immutep Quarterly Activities Report Q1 FY26
Globenewswire· 2025-10-29 12:00
Core Insights - Immutep Limited is advancing its clinical trials for eftilagimod alfa (efti) in oncology and autoimmune diseases, with significant progress reported in multiple trials [2][3][31] Oncology Development Programs - The TACTI-004 (KEYNOTE-F91) Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with over 100 clinical sites activated across 24 countries, aiming to enroll approximately 756 patients [3][4] - The trial has successfully enrolled and randomized over 170 patients, surpassing the number required for a futility analysis, which is expected to be completed in Q1 CY2026 [6] - Positive feedback from the FDA has been received regarding the late-stage clinical development of efti for head and neck cancer patients with low PD-L1 expression [9][11] - The INSIGHT-003 Phase I trial is also evaluating efti in combination with KEYTRUDA® and chemotherapy for non-squamous NSCLC, with data presented at ESMO 2025 [7][8] Soft Tissue Sarcoma and Breast Cancer Trials - The EFTISARC-NEO Phase II trial for soft tissue sarcoma has met its primary endpoint, showing significant tumor hyalinization compared to historical data [16] - The AIPAC-003 trial for metastatic breast cancer has enrolled 71 patients, with ongoing follow-up and data analysis expected to be reported at the San Antonio Breast Cancer Symposium in December 2025 [17][19] Financial Position - As of September 30, 2025, Immutep reported a strong cash position of approximately A$109.85 million, consisting of A$83.41 million in cash and cash equivalents and A$26.44 million in term deposits [27] - The net cash used in R&D activities during Q1 FY26 was A$15.83 million, reflecting increased clinical trial activities [28] Intellectual Property Developments - Immutep was granted four new patents during the quarter, enhancing its intellectual property portfolio related to LAG-3 and its therapeutic applications [24]
Two Posters at ESMO Congress 2025 Highlight Immutep’s Focus on Changing Treatment Landscape in First Line Non-Small Cell Lung Cancer
Globenewswire· 2025-10-20 12:00
Core Insights - Immutep Limited is focusing on changing the treatment paradigm for first-line non-small cell lung cancer (1L NSCLC) through innovative immunotherapy approaches [1][5]. Clinical Trial Results - The INSIGHT-003 trial demonstrated strong objective response rates (ORR) and disease control rates (DCR) for the combination of eftilagimod alfa (efti) with KEYTRUDA (pembrolizumab) and chemotherapy in patients with advanced or metastatic non-squamous 1L NSCLC [2][5]. - The ORR for patients with low and no PD-L1 expression (TPS <50%) reached 61.7%, significantly higher than the historical control of 40.8% [3][5]. - The combination therapy showed high ORR and DCR across all PD-L1 expression levels, with specific rates of 54.5% (no PD-L1), 68.0% (low PD-L1), and 75.0% (high PD-L1) [4]. Safety and Efficacy - The combination of efti with KEYTRUDA and chemotherapy has a favorable safety profile and has shown promising clinical responses, particularly in patients with low or absent PD-L1 expression [3][5]. - Efti is expected to set a new standard of care for 1L NSCLC patients, supported by data from multiple clinical trials, including the pivotal TACTI-004 Phase III trial [5][8]. Future Developments - The TACTI-004 Phase III trial is a global study enrolling approximately 756 patients with advanced/metastatic 1L NSCLC, evaluating the same immunotherapy/chemotherapy combination used in INSIGHT-003 [5][6]. - Efti is under evaluation for various solid tumors, including head and neck squamous cell carcinoma and breast cancer, and has received Fast Track designation from the FDA for first-line treatments [8]. Company Overview - Immutep is a late-stage biotechnology company specializing in novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [9].
Immutep Announces Successful Completion of FDA Project Optimus Requirements
Globenewswire· 2025-10-13 12:00
Core Insights - Immutep Limited has received positive feedback from the FDA regarding the completion of Project Optimus and has agreed on 30mg as the optimal biological dose for eftilagimod alfa (efti) [1][2] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging Lymphocyte Activation Gene-3 (LAG-3) [5] Clinical Development - The agreement on efti's optimal biological dosing is strategically important for ongoing and future clinical development, including the TACTI-004 (KEYNOTE-F91) Phase III trial, which evaluates efti in combination with KEYTRUDA and chemotherapy for advanced or metastatic non-small cell lung cancer [2][4] - The TACTI-004 trial is currently in the process of opening clinical sites in the United States [7] Efti Overview - Efti is a novel immunotherapy that activates antigen-presenting cells via the MHC Class II pathway, engaging both the adaptive and innate immune systems to initiate a broad anti-cancer immune response [3] - Efti is being evaluated for various solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer, and has received Fast Track designation from the FDA for first-line treatments in HNSCC and NSCLC [4]
Immutep Announces Update for TACTI-004 (KEYNOTE-F91) Phase III Trial in First Line Non-Small Cell Lung Cancer
Globenewswire· 2025-10-09 12:00
Core Insights - Immutep Limited is advancing its TACTI-004 Phase III trial for eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer (NSCLC) [1][4] Company Updates - The TACTI-004 trial has enrolled over 170 patients, surpassing the required number for a futility analysis [2][8] - There are now over 100 active clinical trial sites across 24 countries, indicating strong recruitment momentum [2][8] - The futility analysis is scheduled for the first quarter of CY2026, to be conducted by an independent data monitoring committee [3][8] Product Information - Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells to enhance anti-cancer immune responses [10][11] - The trial aims to enroll approximately 756 patients, focusing on those with advanced or metastatic NSCLC without specific genomic aberrations [7][9] Market Context - Lung cancer is the leading cause of cancer-related deaths, with an expected increase to approximately 3 million cases globally by 2030 [5] - NSCLC accounts for about 80-85% of lung cancer diagnoses, highlighting a significant unmet need for effective treatment options [5]
Immutep Quarterly Activities Report Q4 FY25
Globenewswire· 2025-07-30 12:00
Core Viewpoint - Immutep Limited is advancing its clinical-stage biotechnology programs focused on LAG-3 immunotherapies for cancer and autoimmune diseases, with significant progress in multiple trials and a strong financial position as of June 30, 2025 [2][21]. Oncology Development Program - The TACTI-004 Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with 78 sites across 23 countries activated for patient recruitment [3][4]. - The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy, aiming to randomize approximately 756 patients [4]. - Immutep reported a 60.8% response rate and a 90.2% disease control rate in the INSIGHT-003 Phase I trial for non-squamous 1L NSCLC [6]. - In patients with TPS <50%, the triple combination achieved a 59.6% response rate compared to a historical control of 40.8% [7][8]. - The TACTI-003 Phase IIb trial for head and neck cancer showed a median overall survival of 17.6 months, outperforming historical standards of care [9][10]. - The EFTISARC-NEO Phase II trial for soft tissue sarcoma met its primary endpoint, significantly exceeding historical data for tumor hyalinization/fibrosis [12][13]. Autoimmune Disease Development Program - The Phase I trial of IMP761, a LAG-3 agonist antibody, demonstrated significant T cell suppression with a favorable safety profile at a dosing level of 0.9 mg/kg [16][17]. - Initial pharmacodynamic data indicated an 80% reduction in T cell activity, highlighting the potential efficacy of IMP761 in treating autoimmune diseases [18]. Intellectual Property - Immutep was granted four new patents during the quarter, including two for efti in combination with a PD-1 pathway inhibitor and two for IMP761 [19]. Corporate & Financial Summary - The company appointed Stephan Winckels as Chief Medical Officer, bringing over 15 years of oncology drug development experience [20]. - As of June 30, 2025, Immutep reported a cash position of approximately A$129.69 million, exceeding budget expectations [22]. - The net cash used in R&D activities during the quarter was A$15.66 million, reflecting increased clinical trial activities [23].
Immutep to Present Pivotal TACTI-004 Trial in Progress Poster at the 2025 World Conference on Lung Cancer
Globenewswire· 2025-07-29 12:00
The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company's antigen presenting cell (APC) activator, eftilagimod alfa (efti) in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA® (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression (Tumour Proportion Score ...
Immutep Announces Abstracts Accepted for Presentation at the European Society for Medical Oncology Congress 2025
Globenewswire· 2025-07-28 12:00
Core Insights - Immutep Limited, a late-stage immunotherapy company, announced that three abstracts for clinical trials of its MHC Class II agonist, eftilagimod alfa, have been accepted for presentation at the ESMO Congress 2025 in Berlin, Germany [1][2]. Group 1: Clinical Trials and Presentations - A Proffered Paper oral presentation will detail results from the EFTISARC-NEO Phase II trial in resectable soft tissue sarcoma, scheduled for October 19, 2025 [2]. - Data from the INSIGHT-003 Phase I trial in first-line non-small cell lung cancer (1L NSCLC) will be presented as a poster on October 18, 2025 [2]. - An abstract on the pivotal TACTI-004 Phase III trial in 1L NSCLC has been accepted for a Trials in Progress ePoster presentation [2]. Group 2: Company Overview - Immutep is focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging the LAG-3 pathway to stimulate or suppress immune responses [4]. - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [4].
Immutep's Efti with Radiotherapy & KEYTRUDA® (pembrolizumab) Meets Primary Endpoint in Phase II for Soft Tissue Sarcoma
GlobeNewswire News Room· 2025-05-27 12:00
Core Insights - Immutep Limited's investigator-initiated EFTISARC-NEO Phase II trial has successfully met its primary endpoint, demonstrating a significant increase in tumour hyalinization/fibrosis in patients with resectable soft tissue sarcoma (STS) when treated with eftilagimod alfa (efti) combined with radiotherapy and KEYTRUDA® [1][7]. Company Overview - Immutep is a late-stage biotechnology company focused on developing innovative immunotherapies for cancer and autoimmune diseases, particularly leveraging the Lymphocyte Activation Gene-3 (LAG-3) pathway [7]. - The company is pioneering the understanding and advancement of therapeutics related to LAG-3, aiming to provide novel treatment options for patients and maximize shareholder value [7]. Trial Details - The EFTISARC-NEO trial showed a median of 50% tumour hyalinization/fibrosis in a preliminary analysis of 21 patients, significantly exceeding the prespecified median of 35% [3]. - The trial is primarily funded by a grant from the Polish government, with a total enrollment of 40 patients completed in January 2025 [3][4]. Medical Significance - Tumour hyalinization/fibrosis serves as an early surrogate endpoint linked to improved overall survival and recurrence-free survival in STS patients [2]. - STS is classified as an orphan disease with a high unmet medical need and poor prognosis, with an estimated 13,520 new cases and 5,420 deaths in the U.S. in 2025 [4]. Eftilagimod Alfa (efti) Profile - Efti is a proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [5]. - Efti is under evaluation for various solid tumours, including non-small cell lung cancer and head and neck squamous cell carcinoma, and has received Fast Track designation from the FDA for certain indications [6].